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The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak® involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak® has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak® or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Patients randomized to the ProstAtak arm will receive two courses of aglatimagene besadenovec + valacyclovir

Biological: aglatimagene besadenovec

Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

Other Name: AdV-tk

Drug: valacyclovir

Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

Placebo Comparator: Placebo

Patients randomized to the placebo arm will receive two corresponding courses of placebo + valacyclovir

Biological: placebo

Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.

Drug: valacyclovir

Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.

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